Aspirin Dosing for Obesity

Recruiting in Palo Alto (17 mi)

Overseen by Sean Heffron, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: NYU Langone Health

No Placebo Group

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

This study employs a placebo-controlled randomized cross-over design to investigate the impact of body weight and aspirin dose on levels of specialized pro-resolving lipid mediators in blood and neutrophils.

Eligibility Criteria

This trial is for non-smoking adults aged 40-70 who are not pregnant, don't have diabetes, bleeding/clotting disorders, immune deficiencies, or chronic inflammatory diseases. They shouldn't have had recent changes in statin drugs or surgeries affecting the stomach and must not be on certain medications including aspirin.

Inclusion Criteria

I am between 40 and 70 years old.

Exclusion Criteria

You are allergic or intolerant to aspirin.

You are currently smoking cigarettes.

I have taken anti-platelet medication in the last week.

Participant Groups

The study is testing how different doses of aspirin (81mg and 325mg) affect blood levels of substances that help resolve inflammation in obese individuals. It's a placebo-controlled study where participants will receive both doses and a placebo at different times without knowing which one they're getting.

Group I: Aspirin 81mg, Then Aspirin 325mg Experimental Treatment 2 Interventions

After a 3 week placebo run-in period, participants first receive Aspirin 81mg capsule daily for 3 weeks. After a placebo washout period of 3 weeks, they then receive Aspirin 325mg capsule daily for another 3 weeks.

Group II: Aspirin 325mg, Then Aspirin 81mg Experimental Treatment 2 Interventions

After a 3 week placebo run-in period, participants first receive Aspirin 325mg capsule daily for 3 weeks. After a placebo washout period of 3 weeks, they then receive Aspirin 81mg capsule daily for another 3 weeks.

Aspirin is already approved in European Union, United States, Canada, China for the following indications:

🇪🇺 Approved in European Union as Aspirin for:

• Pain relief
• Fever reduction
• Inflammation
• Cardiovascular disease prevention
• Preeclampsia prevention

🇺🇸 Approved in United States as Aspirin for:

• Pain relief
• Fever reduction
• Inflammation
• Cardiovascular disease prevention
• Preeclampsia prevention

🇨🇦 Approved in Canada as Aspirin for:

• Pain relief
• Fever reduction
• Inflammation
• Cardiovascular disease prevention
• Preeclampsia prevention

🇨🇳 Approved in China as Aspirin for:

• Pain relief
• Fever reduction
• Inflammation
• Cardiovascular disease prevention

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

NYU Langone Health New York, NY

Who Is Running the Clinical Trial?

NYU Langone Health Lead Sponsor

References